MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROVPPSOLO 4FDL MBP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reep3971 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported bedside nurse reports that on day one pump continued to alarm when patient was receiving chemo and it was difficult to obtain blood sample.This was reported to the vat the day after insertion.Chest x-ray and x-ray of the arm were obtained and a kink in the arm was detected.Dl picc was replaced with a tl.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kink is confirmed; however, the root cause could not be determined.One photo of an arm x-ray was returned for evaluation.An initial visual observation of the photograph showed an arm x-ray.The catheter is visible in the arm.Shortly after entering, the catheter kinks and reverses direction.The catheter then curves and continues progressing up the arm.While a catheter kink was clearly visible in the submitted photographs, inspection of those photographs was insufficient to identify the cause of the kink.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include weakened material due to flexural fatigue, placement technique, securement technique, and patient anatomical features.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of reep3971 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported bedside nurse reports that on day one pump continued to alarm when patient was receiving chemo and it was difficult to obtain blood sample.This was reported to the vat the day after insertion.Chest x-ray and x-ray of the arm were obtained and a kink in the arm was detected.Dl picc was replaced with a tl.

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10490949
• Report Number: 3006260740-2020-03127
• Device Sequence Number: 2476294
• Product Code: LJS
• UDI-Device Identifier: 00801741154898
• UDI-Public: (01)00801741154898
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: S1294108D2
• Device Lot Number: REEP3971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1